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The Effect of the Hydroxyethyl Starch on Kidney Injury in Pediatric Cardiac Surgery

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02599155
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
4
Duration (Months)
50.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigator will evaluate the influence of colloid administration on postoperative acute kidney injury in pediatric patients undergoing cardiac surgery under cardiopulmonary bypass.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

The investigator will randomly divide pediatric patients aged less than 7 years old into crystalloid and colloid groups. Crystalloid group receive only crystalloid, and colloid group receive hydroxyethyl starch (HES, 130/0.4). The maximum volume of HES is limited less than 30 ml/kg. The same transfusion protocol will be applied in both groups. From the day of operation to postoperative 7 days, glomerular filtration rate (GFR), serum creatinin level (Cr) will be checked. Acute kidney injury (AKI) is defined when there is more than 50% increase in Cr when compared to baseline level. The investigator will compare the clinical outcomes including AKI between two groups.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Effect of the Hydroxyethyl Starch on Kidney Injury in Pediatric Cardiac Surgery
Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Crystalloid group

Crystalloid group receive only crystalloid for intravenous volume expansion. The same transfusion protocol is applied in both groups.

Drug: Crystalloid
normal saline administration for volume expansion in hypovolemic status
Other Names:
  • normal saline

    		•
    Active Comparator: Colloid group

    Colloid group receive colloid preferentially for intravenous volume expansion, until 30 ml/kg. The same transfusion protocol is applied in both groups.

    Drug: Colloid
    HES 130/0.4 administration for volume expansion in hypovolemic status
    Other Names:
  • HES 130/0.4

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Acute Kidney Injury [From the day of surgery to postoperative 7 days]

    Secondary Outcome Measures

    1. Blood loss [From the day of surgery to postoperative 7 days]

    2. Transfusion amount [From the day of surgery to postoperative 7 days]

    3. Mechanical ventilation time [From the day of surgery to postoperative 7 days]

    4. Length of ICU stay [From the day of surgery to postoperative 7 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 7 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Children aged less than 7 years old

    • American Society of Anesthesiology (ASA) physical status 1-3

    Exclusion Criteria:

    • Preoperative creatinine > 1.5mg/dl

    • History of dialysis

    • Liver function abnormality

    • Diabetes Mellitus

    • History of allergic reaction

    • Coagulation abnormality

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul national university hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Jin-Tae Kim, PhD, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jin-Tae Kim, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT02599155
    Other Study ID Numbers:
    • H1507-061-687
    First Posted:
    Nov 6, 2015
    Last Update Posted:
    Jun 26, 2017
    Last Verified:
    Jun 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Jin-Tae Kim, Professor, Seoul National University Hospital
    crystalloid
    colloid
    children
    infant
    cardiac surgery
    Additional relevant MeSH terms:
    Acute Kidney Injury
    Wounds and Injuries

    Study Results

    No Results Posted as of Jun 26, 2017